GSK

Regulatory Project Manager

GSK

full-time

Posted on:

Location Type: Hybrid

Location: Poznan • Poland

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Salary

💰 PLN 183,750 - PLN 306,250 per year

About the role

  • Take ownership for multiple complex CMC regulatory submissions, including planning, coordination and execution, to support applications for marketing authorizations, lifecycle activities and maintenance of registered products across Vaccines portfolio, in accordance with the applicable regulatory and scientific standards.
  • Manage multiple project assignments simultaneously, including CMC variations and handling Health Authority Questions (HAQs) for Finished Products, Intermediates, and Active Pharmaceutical Ingredients for Vaccines products (i.e. largely involving updates to the CTD Module 3, Quality section of the dossiers).
  • Identify risks associated with submission data and information package; and support the development of mitigation strategies.
  • Collaborate closely with cross-functional teams, such as Global Regulatory Lead’s team, Global Supply Chain (GSC), Quality Assurance (QA), Local Operating Companies (LOCs), and third Parties to build regulatory CMC submissions and maintain strong relationships, including with senior stakeholders.
  • Identify improvement opportunities for CMC Regulatory processes, policies, instructions and systems, developing and implementing simplified working practices and procedures to enhance efficiency and quality.
  • Serve as Subject Matter Expert (SME) for CMC Regulatory Affairs, mentoring and guiding team members, while sharing best practices to build capability and knowledge within the CMC Regulatory teams and other impacted functions.

Requirements

  • Advanced degree (Master's or above) in Pharmacy, Biotechnology, Biology, Chemistry/Biochemistry or other closely related medical/life science field.
  • Strong experience in CMC Regulatory Affairs within pharmaceutical industry or research organization.
  • Extensive expertise in regulatory strategy planning, dossier preparation (CTD Module 1-3), technical dossier review and in all associated CMC regulatory aspects.
  • Sound understanding of the pharmaceutical industry, drug development environment, regulatory processes and ICH guidelines and requirements, including EU regulatory framework.
  • Exceptional flexibility, analytical thinking and growth mindset.
  • Excellent interpersonal skills; including clear and effective written and verbal communication, and the ability to build strong relationships across a diverse, large organization.
  • English writing skills.
  • Excellent organizational skills, ability to handle multiple tasks, prioritize effectively and deliver high quality output under imposed deadlines, with a strong attention to detail (with emphasis on accuracy and completeness).
Benefits
  • private healthcare
  • additional paid days off
  • life insurance
  • private pension plan
  • fully paid parental leave & care of family member leave
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
CMC regulatory submissionsregulatory strategy planningdossier preparationCTD Module 1-3technical dossier reviewregulatory processesICH guidelinesEU regulatory frameworkrisk identificationmitigation strategies
Soft Skills
analytical thinkingflexibilitygrowth mindsetinterpersonal skillswritten communicationverbal communicationrelationship buildingorganizational skillsprioritizationattention to detail
Certifications
advanced degreeMaster's degreePhD